Class III · Low risk
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Wrong potency or content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk.
992 FDA drug recalls with this cause, newest first.
These recalls cover sub-potent or super-potent products, or a failed content-uniformity test - meaning some pills in the same batch held noticeably different amounts of active ingredient than others. Either way it is a direct dosing risk: too little to work, or too much and harmful. Thyroid hormones and compounded injectables are the classic examples, because their dose window is narrow.
Class III · Low risk
Fred's Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Equaline Original Prescription Strength
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Discount Drug Mart Food Fair
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
CVS Pharmacy
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
CareOne Original Prescription Strength
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Health Best Choice Care
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Rite Aid Pharmacy loratadine orally disintegrating tablets USP
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
QC Quality Choice Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class I · High risk
fentaNYL Citrate
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Class II · Moderate risk
HEPARIN Sodium Inj. USP
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
fentaNYL Citrate Injection
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Class III · Low risk
Mometasone Furoate Ointment USP
Subpotent drug
Class III · Low risk
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…
Subpotent Drug: menthol and methyl salicylate below specification
Class III · Low risk
Cortisol-Mc
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Class II · Moderate risk
OXYCODONE HCl C-II Tablets
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Class III · Low risk
Dr Blue Pain Relieving Gel
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Class II · Moderate risk
Heparin Sodium and 0.9% Sodium Chloride Injection
Subpotent Drug; out of specification results for heparin raw material
Class II · Moderate risk
Enalapril maleate and hydrochlorothiazide tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Losartan potassium tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Losartan potassium tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Losartan potassium tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class I · High risk
Morphine Sulfate
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
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